A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE)

Miriam Kuppermann; Alice Pressman; Kimberly Coleman-Phox; Patience Afulani; Bridgette Blebu; Kristin Carraway; Brittany Chambers Butcher; Venise Curry; Chris Downer; Brittany Edwards; Jennifer N Felder; Jazmin Fontenot; Mary A Garza; Deborah Karasek; Lauren Lessard; Erica Martinez; Charles E McCulloch; Christy Oberholzer; Guadalupe R Ramirez; Martha Tesfalul; Andrea Wiemann

doi:10.1016/j.cct.2024.107568

A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE)

Contemp Clin Trials. 2024 May 14:143:107568. doi: 10.1016/j.cct.2024.107568. Online ahead of print.

Authors

Miriam Kuppermann¹, Alice Pressman², Kimberly Coleman-Phox³, Patience Afulani⁴, Bridgette Blebu⁵, Kristin Carraway⁶, Brittany Chambers Butcher⁷, Venise Curry⁶, Chris Downer⁸, Brittany Edwards⁶, Jennifer N Felder⁹, Jazmin Fontenot³, Mary A Garza¹⁰, Deborah Karasek³, Lauren Lessard¹¹, Erica Martinez⁶, Charles E McCulloch², Christy Oberholzer⁶, Guadalupe R Ramirez¹², Martha Tesfalul³, Andrea Wiemann⁶

Affiliations

¹ Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America. Electronic address: miriam.kuppermann@ucsf.edu.
² Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America.
³ Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.
⁴ Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.
⁵ The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States of America.
⁶ Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.
⁷ Department of Human Ecology, College of Agricultural and Environmental Sciences, University of California, Davis, Davis, CA, United States of America.
⁸ Medical Education Program, University of California, San Francisco, Fresno, CA, United States of America.
⁹ Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.
¹⁰ Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America; Department of Public Health, College of Health and Human Services, California State University, Fresno, Fresno, CA, United States of America.
¹¹ Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America; Institute for Circumpolar Health Studies, University of Alaska, Anchorage, Anchorage, AK, United States of America.
¹² Children and Families Commission of Fresno County, Fresno, CA, United States of America.

PMID: 38750950
DOI: 10.1016/j.cct.2024.107568

Abstract

Background: Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. An enhanced group prenatal care program, "Glow! Group Prenatal Care and Support," was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes.

Methods: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medi-Cal (California's Medicaid program)-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials.

Conclusions: This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use.

Trial registration: ClinicalTrials.gov: NCT04154423.

Keywords: Anxiety; Depression; Postpartum depression; Pragmatic clinical trial; Pregnancy; Prenatal care; Preterm birth.

Associated data

ClinicalTrials.gov/NCT04154423